Evaluation of an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/10/2019 |
| Start Date: | August 14, 2017 |
| End Date: | June 30, 2019 |
| Contact: | Carmen A Peralta, MD, MAS |
| Email: | CarmenAlicia.Peralta@ucsf.edu |
| Phone: | 415-476-2173 |
A Randomized Trial to Evaluate an Electronic CKD Clinical Decision Support System (CDSS) in Clinical Care
The investigators propose a three-arm, pragmatic, cluster-randomized clinical trial based in
primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or
one of two intervention arms. The first intervention will evaluate the efficacy of an
automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker
test ordering, guideline implementation and BP management, compared with usual care, among
patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention
goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a
pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge
among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP
level, with secondary outcomes related to processes of care and patient knowledge.
primary care. Participating Primary Care Providers (PCPs) will be randomized to usual care or
one of two intervention arms. The first intervention will evaluate the efficacy of an
automated CDSS that utilizes the electronic health record (EHR) to facilitate triple marker
test ordering, guideline implementation and BP management, compared with usual care, among
patients with previous documentation of eGFRcreat <60 ml/min/1.73m2. The second intervention
goes a step further, and will evaluate whether a CDSS plus a follow-up telephone call from a
pharmacist (CDSS PLUS) can improve BP management and patient CKD and NSAID toxicity knowledge
among the patients with CKD, compared with CDSS alone. The primary clinical outcome is BP
level, with secondary outcomes related to processes of care and patient knowledge.
Setting:
The investigators will conduct this study within the three General Internal Medicine (GIM)
practices at UCSF. These include general internal medicine PCPs who practice primary care.
This trial is specifically designed to work within the framework of the existing
infrastructure of these practices.
Randomization:
The unit for randomization will be the PCP (MD and NPs with their own panel of patients); the
investigators plan to include up to 105 PCPs.
Training and Pre-Trial Preparation:
Prior to the beginning of this trial, all eligible providers at the UCSF GIM practice will be
informed of this trial by the PI via email, attached with consent information, at which time
they will be sent a link to information about the Kidney Disease Improving Global Outcomes
(KDIGO) guidelines, and they will have the opportunity to opt-out of the trial. PCP
randomization will be performed by the study coordinator using an automated procedure. The
PCPs randomized to the intervention arms (CDSS and CDSS PLUS) will have the option to view a
brief training video designed by study PIs and IT experts on the automated CKD CDSS.
Blinding:
The analysts will remain blinded throughout the trial and data analyses.
Intervention Details (CKD CDSS):
The CKD CDSS has been developed by the study PIs and IT experts, and refined using physician
feedback. While the tool will be automated as much as possible using the electronic medical
record, provider decision making will be required at all diagnostic or treatment steps in the
CDSS.
The study MD will order all of the triple marker CKD tests not yet done(creatinine, urine
microalbumin, cystatin C). Once the tests are ordered, patients will proceed to the
laboratory as they normally would in clinical practice. The EHR will be programmed to return
the results to the PCP's clinical results folder in APeX, and to a study inbox monitored by
the study MDs. Participating PCPs will be advised about tests being ordered along with a list
of their eligible patients when sent the opt out letter prior to being randomized.
Best Practice Alert (BPA), Smart Set: The CDSS will allow a "second-chance" for test ordering
if the tests are not completed prior to an enrolled patient encounter (for PCPs in the CDSS
or CDSS Plus arms), by automatically delivering a reminder message embedded in the visit
encounter as part of a best practice alert (BPA) indicating that the triple marker tests have
been ordered but not completed for this patient. If the tests have been completed at the time
of the visit, the BPA will give CKD staging based on the triple marker for the individual
patient and have a button to click to open a smart smart-set tailored to that specific
patient. The smart-set will cover the orders and recommendations as indicated for that
patient: Blood pressure target, use of ACEI/ARB class of medications, potassium management,
use of statin medications, pre-populated referral to nephrology when indicated, patient
educational material on NSAIDS and CKD in general to populate the After Visit Summary.
CDSS PLUS: The rationale for this third arm is based on the evidence that clinical
pharmacists have been shown to be more effective than physicians alone at achieving BP
control in other settings. For PCPs in the CDSS PLUS intervention arm, the study will provide
cards identifying the pharmacist on the clinical team. During the visit in which the CDSS
launches, the PCPs can let the patient know that a pharmacist, who is part of the clinical
team, will be calling to follow-up, and he/she can hand these cards out to eligible patients.
In addition, the CDSS smart set for these patients will give information about the pharmacist
that can populate the After Visit Summary. This warm hand-off will allow the patient to be
aware of the reason for the pharmacist's post-visit call. For patients active on MyChart, the
pharmacist will use MyChart to set up a good time to call the patient within two weeks. If
the patient does not use MyChart, the pharmacist will attempt to call and leave messages for
the patient. On the phone call, the pharmacist will discuss and collect data on the patient's
understanding of CKD, conduct a medication review and adherence assessment, ask about home BP
checks, and discuss the importance of NSAID avoidance.
All calls will be documented in APeX to allow the entire clinical team to follow the
patient's care and route messages to the PCP and team RN as necessary. A second call from the
pharmacist will only be triggered if the patient is non-adherent and makes an active plan for
adherence requiring a follow-up call to check-in on that plan, or if the patient requests an
additional follow-up call.
The investigators will conduct this study within the three General Internal Medicine (GIM)
practices at UCSF. These include general internal medicine PCPs who practice primary care.
This trial is specifically designed to work within the framework of the existing
infrastructure of these practices.
Randomization:
The unit for randomization will be the PCP (MD and NPs with their own panel of patients); the
investigators plan to include up to 105 PCPs.
Training and Pre-Trial Preparation:
Prior to the beginning of this trial, all eligible providers at the UCSF GIM practice will be
informed of this trial by the PI via email, attached with consent information, at which time
they will be sent a link to information about the Kidney Disease Improving Global Outcomes
(KDIGO) guidelines, and they will have the opportunity to opt-out of the trial. PCP
randomization will be performed by the study coordinator using an automated procedure. The
PCPs randomized to the intervention arms (CDSS and CDSS PLUS) will have the option to view a
brief training video designed by study PIs and IT experts on the automated CKD CDSS.
Blinding:
The analysts will remain blinded throughout the trial and data analyses.
Intervention Details (CKD CDSS):
The CKD CDSS has been developed by the study PIs and IT experts, and refined using physician
feedback. While the tool will be automated as much as possible using the electronic medical
record, provider decision making will be required at all diagnostic or treatment steps in the
CDSS.
The study MD will order all of the triple marker CKD tests not yet done(creatinine, urine
microalbumin, cystatin C). Once the tests are ordered, patients will proceed to the
laboratory as they normally would in clinical practice. The EHR will be programmed to return
the results to the PCP's clinical results folder in APeX, and to a study inbox monitored by
the study MDs. Participating PCPs will be advised about tests being ordered along with a list
of their eligible patients when sent the opt out letter prior to being randomized.
Best Practice Alert (BPA), Smart Set: The CDSS will allow a "second-chance" for test ordering
if the tests are not completed prior to an enrolled patient encounter (for PCPs in the CDSS
or CDSS Plus arms), by automatically delivering a reminder message embedded in the visit
encounter as part of a best practice alert (BPA) indicating that the triple marker tests have
been ordered but not completed for this patient. If the tests have been completed at the time
of the visit, the BPA will give CKD staging based on the triple marker for the individual
patient and have a button to click to open a smart smart-set tailored to that specific
patient. The smart-set will cover the orders and recommendations as indicated for that
patient: Blood pressure target, use of ACEI/ARB class of medications, potassium management,
use of statin medications, pre-populated referral to nephrology when indicated, patient
educational material on NSAIDS and CKD in general to populate the After Visit Summary.
CDSS PLUS: The rationale for this third arm is based on the evidence that clinical
pharmacists have been shown to be more effective than physicians alone at achieving BP
control in other settings. For PCPs in the CDSS PLUS intervention arm, the study will provide
cards identifying the pharmacist on the clinical team. During the visit in which the CDSS
launches, the PCPs can let the patient know that a pharmacist, who is part of the clinical
team, will be calling to follow-up, and he/she can hand these cards out to eligible patients.
In addition, the CDSS smart set for these patients will give information about the pharmacist
that can populate the After Visit Summary. This warm hand-off will allow the patient to be
aware of the reason for the pharmacist's post-visit call. For patients active on MyChart, the
pharmacist will use MyChart to set up a good time to call the patient within two weeks. If
the patient does not use MyChart, the pharmacist will attempt to call and leave messages for
the patient. On the phone call, the pharmacist will discuss and collect data on the patient's
understanding of CKD, conduct a medication review and adherence assessment, ask about home BP
checks, and discuss the importance of NSAID avoidance.
All calls will be documented in APeX to allow the entire clinical team to follow the
patient's care and route messages to the PCP and team RN as necessary. A second call from the
pharmacist will only be triggered if the patient is non-adherent and makes an active plan for
adherence requiring a follow-up call to check-in on that plan, or if the patient requests an
additional follow-up call.
Inclusion Criteria:
- Have at least two outpatient, documented eGFRcreat values 30- 59 ml/min/1.72m2 that
are at least ≥3 months apart
- At least one of these measurements should be within 12 months.
- Patients have seen their primary care physician at least one time within the previous
18 months
- Patient's primary care providers agree to participate
Exclusion Criteria:
- Patients actively and recently seen by nephrology clinic (at least once in the past 12
months)
- Patients with a diagnosis of end stage renal disease
- Persons aged >80
- Persons with New York Heart Association (NYHA) class III or IV heart failure, known
ejection fraction < 25%, or documented allergy to ace/arb.
- Patients on dialysis, kidney transplant recipients and pregnant women
- Patients with prevalent dementia, impaired cognition or severe mental illness;
expected life expectancy < 6 months.
There will also be a category where the physician can opt out for specific patients in
their panel due to not believing this person should be included in the study for any
reason.
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